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PierianDx Raises $9M to Update Software to Support Clinical WGS, Improve Sharing

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NEW YORK (GenomeWeb) – Bioinformatics firm PierianDx said today that it has raised $9.25 million in a Series A financing round led by Health Catalyst Capital Management that it is using to further develop its commercial offering and expand its business.

Other participants in the financing round included Inova Translational Medicine Institute, ARUP Laboratories, and a venture investing affiliate of Ocean Road Advisors.

PierianDx is using the funds to develop new capabilities for its Clinical Genomicist Workstation (CGW) product. The software, which was developed by researchers at Washington University in St. Louis and licensed by PierianDx, provides tools for analyzing, interpreting, and reporting the results of clinical next-generation sequencing-based tests focused on somatic cancers and constitutional disorders. 

The company is also using some of the funds to hire curators to help expand the content contained in the software's underlying knowledgebase of information, PierianDx CEO Ted Briscoe told GenomeWeb. It began expanding its database last year to include not just information from repositories such as ClinVar, COSMIC, TCGA, dbSNP, HGMD, and the 1000 Genomes Project, but also curated information on clinical trials, US Food and Drug Administration drug labels, and treatment guidelines from the National Comprehensive Cancer Network and the American Society of Clinical Oncology. The company also added a so-called PDx score to help clinicians prioritize actionable variants from lists of mutations generated by their tests.

PierianDx is also investing other funds in new functionalities for CGW, the first of which will be rolled out this quarter. The list of planned features includes support for clinical whole genome analysis workflows including tailored tools for reporting results, Briscoe said. The company is also improving the data sharing capabilities of its software to make it easier for participants in its partner network to share data and workflows.

"We have systematically increased from this being a somatic cancer-focused service when we licensed the asset from Washington University to a much broader set of functionalities that includes a pretty wide range of constitutional disorders," Briscoe said.

So far the company has signed on 16 customers for the CGW including health systems, academic medical centers, and commercial labs. The list of customers includes Phoenix Children's Hospital, which began partnering with PierianDx in 2014 to develop and validate a sequencing-based test for use in a pediatric cancer study. CGW also supports NGS-based clinical tests performed by ARUP Labs, one of the investors in PierianDx's current financing round; and the company has an agreement to combine its platform with Syapse's to offer an end-to-end genomic testing workflow aimed at pathology laboratories.

The needs of these and other customers, in part, drive PierianDx's decisions on what content to include in its database and what functionality to add to its software. For example, the company is adding support for clinical whole genome analysis in direct response to a specific need from one of its customers, Briscoe said. He declined to disclose who the customer is and what capabilities the CGW is developing to support its efforts. However, he did say that the company is currently testing the clinical WGS features it has developed and will share details of this particular partnership in the near future.

But some of the company's development efforts are based on perceived needs. For instance, "the market interest is very high in terms of sharing [and] this is a big part of our value proposition and I think an important differentiator in the marketplace," Briscoe said. Clients who choose to participate in the company's partner network can share information on things like assay design and methodology, de-identified patient information, and clinical interpretations using its infrastructure. The additional sharing tools that the company plans to roll out over the next quarter are intended to provide much deeper support for clients and address issues that "we know are important based on macro-level interest and trends in the market," he said.

PierianDx is also seeking to support customer labs that are looking to launch their own testing services. To that end, the company launched the NGS Gateway Program last month, which is a service designed to connect budding testing labs to the resources they need to begin offering tests while they work on setting up the requisite internal infrastructure and securing the appropriate certifications.

"While reference labs are a fantastic, well-established avenue to get these types of tests done, we've seen more and more partners interested in having their own CLIA license and offering these tests on their own," Briscoe explained. These clients have different motivations for wanting to keep the entire testing pipeline in house. For example, some prefer to have their own pathologists reviewing and signing out cases for consistency's sake while others want to keep testing revenues in house rather than share them with third parties.

"But its primarily driven by their belief that precision medicine is an inevitable part of the future and that to enhance and protect their own brand, they should be practicing this medicine themselves as opposed to just sending it out to a third party," Briscoe said.

PierianDx's program is designed to provide short-term services to these CGW users as they work to develop and validate their test offerings. Through the program, the company can connect them with sequencing service providers to handle sample prep and sequencing as well as medical professionals to review and sign out testing results just until they can get their services up and running. Customers pick which services they require and the company matches them to partner providers that offer validated tests for the conditions in question.

"What we offer is a full range of services so that partners can use us for a variety of things and not just the sequencing. We are doing this under their brand so the reports that we generate are under that partner's brand," Briscoe explained. It's a much broader range of service options than a pure sequencing outsource partner like Illumina, for example, would provide. "Those are not propositions that we are really competing against," he said.

So far PierianDx offers outsource services for tests focused on solid tumor, hematopoietic disorders, CNS tumors, and melanoma through the program and it plans to add more tests over the course of the year focused on constitutional or germline conditions. All these tests are conducted in CAP-accredited, CLIA-certified labs — Briscoe declined to disclose who the company's partner service providers are.

PierianDx can also work with customers of the service to customize their assays. Pricing for the Gateway Program depends on which services the customer needs and which assays they want to offer. Briscoe declined to provide specifics on pricing but he did say that company's prices are "very competitive." So far, the company has signed four lab service agreements since the program launched and has started helping two of those labs access services, Briscoe said. The company is not disclosing who these clients are.

In addition to hiring curators and expanding its software, PierianDx is also using the funds from the recent financing round to hire sales and support staff. In total, the company hopes to hire on the order of 15 people split between its offices in the US and India bringing its total headcount to about 55 people.

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